SHINE brings a light of hope to cancer and heart patients

The following story is one in a series of features on Wisconsin companies that are doing promising work in the global fight against cancer.

While molybdenum-99 might sound like a term carefully crafted in the musty basement office of an aspiring Star Trek scriptwriter, it’s a real, and vitally important, isotope that’s crucial to many modern diagnostic procedures.

Unfortunately, the only reason you’re likely to hear about it is that it’s in critically short supply. Fortunately, the market abhors a vacuum, and SHINE Medical Technologies, a Monona company that’s finalizing plans to build a new $100 million facility in Janesville, is gearing up to fill it.

“Our whole model is based on a cheaper, safer, more environmentally friendly way to make this stuff,” said SHINE CEO Gregory Piefer. “The interesting thing is, the existing producers are all foreign-controlled nuclear reactors, and they’re all very old, and they’re not working very well anymore.

“I used to drive an old Saturn, and it was very old and it broke a lot and I needed to fix it a lot, and these reactors are very similar. The trouble is, when they break, the product that we make, moly-99, has a half-life of 66 hours, so you can’t stockpile it. You can’t plan for a rough day. So when they break, the market gets hurt and people who need those procedures don’t get them.”

A glaring need

Molybdenum-99 is a precursor to technetium-99m, an isotope that’s administered to approximately 55,000 U.S. patients each day to diagnose and stage conditions such as heart disease and cancer. Unfortunately, existing facilities’ inability to keep up with demand has led to serious shortages, and that’s left health care providers reeling.

“You can imagine a scenario where you or someone you love has been experiencing chest pains for the last several hours or even days, and you decide to go into the hospital and the hospital says we need to look at your heart to see if there’s a blockage there, see if the heart muscle’s dying,” said Piefer. “During these shortages, doctors either have to perform alternative procedures that don’t work as well, give you alternative radioisotopes that don’t work as well and give you a much higher radiation dose, or in some cases send you home and tell you they can’t do this for another few weeks.

“Our whole model is based on a cheaper, safer, more environmentally friendly way to make this stuff.” – Gregory Piefer, CEO, SHINE Medical Technologies

“That’s not what you want to hear if your heart’s in the process of dying. And so it’s a very big deal, and the disruptions were very upsetting to doctors.”

Because SHINE’s innovative process relies on a low-energy neutron source instead of a reactor, it offers obvious safety advantages. The company also anticipates it will be able to meet more than half of the U.S.’s demand for molybdenum-99 by 2014 and do so more inexpensively than reactors can.

Of course, while the importance of SHINE’s plans to the medical field are obvious, they’re also a testament to the dynamism and adaptability of markets. When SHINE got into the isotope business, it wasn’t necessarily thinking about helping heart patients or curing cancer.

“Actually, SHINE was formed out of a company called Phoenix Nuclear Labs, and Phoenix had this neat neutron-source technology, and we knew we could use the neutrons to make radioisotopes, but we were focused on other industries for neutrons, taking pictures, radiography,” said Piefer. “So the moly market wasn’t super interesting because there were two new reactors being built in Canada, and each of those reactors was supposed to cover the world, but those reactors went way over budget, and then when they turned them on the first time, they demonstrated a fundamental safety flaw.

“The Canadians spent another eight or so years and another half-billion dollars trying to track it down, and they failed to track down the reason for it, and in 2008, they killed that program, and then all of a sudden the moly market looked really interesting. There was no future supply.”

The light of exploration

In addition to molybdenum-99, SHINE will also be able to make Iodine-131, Iodine-125, and Xenon-133. Iodine-131 is currently used to treat thyroid cancer and other thyroid conditions, Xenon-133 is used to evaluate lung function, and Iodine-125 is used in brachytherapy, a treatment commonly used to fight prostate cancer and brain tumors.

That last isotope is one SHINE promises to explore further to see if a market firms up for it.

“I-125 is something that we’re going to have to choose whether or not to make,” said Piefer. “We can make it, but we need to determine if the market is interesting enough. But I-125 is used to make seeds, these little seeds that they implant in a cancer tumor to slowly kill it.”

While SHINE’s technology promises to be safer than a conventional nuclear reactor, there are still potential hazards involved, and the National Regulatory Commission still has to give the company’s facility the green light. According to Piefer, the main hurdles the company has to clear are securing a construction permit and an operating license, but he anticipates no stumbling blocks.

So far, SHINE’s funding has come from a mix of private and public sources. Early-stage investors have stepped up to the plate, and the company has also gotten prodigious support from the federal government. In May, the Department of Energy announced a $20 million grant to SHINE and the Morgridge Institute for Research to accelerate the development of the molybdenum-99 production process.

This came just months after the company announced it would build its production facility in Janesville. The highly anticipated announcement was the culmination of lots of planning on SHINE’s part and lots of lobbying on the part of several municipalities. While one might be tempted to conclude that divine intervention was in play (considering the run of economic bad luck the city has experienced in recent years), according to Piefer, the location was simply the most logical choice. Proximity to markets and transportation both played a role, as did geology.

“We have a customer base that is sort of scattered around the Midwest; we have customers near Boston, we have customers in St. Louis, we have customers in Ottawa, Canada, and then anything else is international,” said Piefer. “But for the U.S. market, the North American market, Wisconsin is very central. It’s very nice. We could have also made a case to be closer to St. Louis, but there is significant seismic activity there because of the New Madrid Fault, so we liked the geographic properties of the Janesville area.

“We looked at things that affected construction costs, such as water table depth, and the depth of the water table in Janesville is deep, 60 to 70 feet. Our facility won’t go anything close to that deep, so we don’t have to worry about water incursion. And then the airport is right across the street from us. When you’ve got a product that decays roughly 1% per hour, getting it to your customers is essential.”

As for the future of SHINE, Piefer says he hopes to have the Janesville plant up and running by 2014. In the meantime, the company is not through raising money.

“We’re just starting a B round of financing,” said Piefer. “We’re interested in raising up to $25 million this round. … I think venture capital sort of fits the bill at this stage for this company. We are looking for other sources of financing as well that would be more strategic in nature, but I think there will be a venture capital component for sure.”